Production Operator

Job Title: Production Operator

Category: Non-Exempt

Department/Group: Production / Operations

Supervisor: Associate Director

Shift: Second Shift

Location: 1 Duncan Drive, Cranbury

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives, and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

Job Description

Job Purpose:

Responsible for the execution of all aspects of solid-dosage manufacturing which includes, but is not limited to, the dispensing, granulation, sifting, milling, drying, encapsulation, coating, compression, and cleaning related activities. Must be able to interact daily with all site support personnel as required. Must be able to complete all required batch record documentation in a thorough, accurate, and legible manner in English. Must be capable of reading and understanding all documented Standard Operating Procedures in English plus demonstrate competency through action and written evaluation.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations.
• Participate in all Quality Investigations as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the cGMP area is cleaned and maintained following all SOPs and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

SUPERVISORY RESPONSIBILITIES:

This job position has no supervisory responsibilities for all hourly (non-exempts) employees.

EDUCATION AND/OR EXPERIENCE:

• High School Diploma or GED Equivalent (2–5 years related experience in cGMP production operation activities)
• Bachelor’s degree in Physical Sciences or Pharmaceutical life science related field of study (0–2 years related experience in cGMP production operation activities)

To perform this job successfully, an individual should have:

• Familiarity with working in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Excellent written communications skills.
• Demonstrated effective verbal communication and interpersonal skills.
• Familiarity with various cGMP solid dosage Pharmaceutical manufacturing equipment. Able to setup, operate, clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
• Able to work with minimal supervision.
• Able to stand on feet throughout an eight-hour work day.
• Able to lift up to 30 lbs. (14 Kgs) without assistance.
• Maintain personal hygiene habits consistent with working in a cGMP environment.
• Be capable of wearing all required PPE;
  including partial and full facepieces based on OSHA guidelines.

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.